Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Postmarketing Study Oversight To Benefit From Informatics Upgrades

Executive Summary

Changes in legacy DARRTS system, transition to new platform and standardized format for annual report submission should improve FDA's tracking of postmarketing requirements, agency tells Office of the Inspector General.

You may also be interested in...



US FDA Drug Review Goals Should Be Faster In PDUFA VII, Industry Negotiators Propose

Sponsor representatives also want postmarketing discussions moved to earlier in the assessment cycle.

Pediatric Study Compliance Could Face Scrutiny In PDUFA Renewal

FDA says compliance is on par with other postmarketing requirements, but jury is still out on whether public posting of noncompliance letters has been effective tool to ensure timely trial completion.

Do Drugs Given Expedited Approval Have More Safety Risks? GAO Says FDA Can't Tell

Findings could give pharmacovigilance prominence alongside 'breakthrough' and other speed mechanisms in legislative debate on agency reform.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS118831

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel